1. Field of the Invention
The present invention relates to a fecal or waste management appliance, and to a method and apparatus for introducing the appliance into a body cavity, and more particularly to a fecal management appliance including a tubular element with a balloon carrying distal end formed entirely of soft, compliant material, that includes integral inflation and irrigation lumens, and has a detachable collection receptacle rotatably connected to its proximal end, and to a method and a separate apparatus for introducing the distal end of appliance into a body cavity.
Contamination by fecal matter of skin, open wounds, burns, sutured surgical incisions and the like located proximate the rectum or stoma may be extremely detrimental to patient recovery. Further, healthcare professionals that accidentally come in contact with such waste while caring for patients with those conditions, many of which have severe medical problems requiring intense care, may unintentionally spread infectious diseases.
Accordingly, it is highly desirable to have a system for the management and collection of bowel contents that effectively prevents contamination of the patient and of the healthcare workers providing care to the patient.
2. Description of Prior Art Including Information Disclosed Under 37 CFR 1.97 and 1.98
One such system designed to provide bowel management is marketed by Zassi Medical Evolutions, Inc. of Fernandina Beach, Fla. 32034. The Zassi system consists of an elongated flexible catheter, the proximal end of which is detachably connected to a waste collection bag. The distal end of the catheter is designed to be inserted through the rectum into the bowel of the patient.
The distal end of the Zassi catheter includes a resilient portion to permit insertion and positioning of the catheter into the bowel. The catheter carries two inflatable balloons, one balloon being situated within the catheter lumen. The other surrounds the catheter at the site of the inside balloon. The balloons are separately inflatable to block the distal end of the catheter and to seal the catheter to the rectum or stoma, respectively. A separate inflation lumen is provided for each balloon. A third lumen delivers irrigation fluid to the bowel.
Dual balloon systems of this type are known and are disclosed in U.S. Pat. No. 5,569,216 issued Oct. 29, 1996 to Kim, entitled “Multipurpose Colostomy Device Having Balloons On An End Thereof” and in International Publication Number WO 02/26293, published Apr. 4, 2002, and entitled “Improved Colostomy Device.”
Dual balloon systems of this type can be complex and costly. Other known rectal catheters have a drawback. That drawback relates to the pressure exerted by the balloons upon the adjacent tissue, during and after inflation.
Other types of catheters, sometimes known as Foley catheters, are large versions of devices commonly used for urinary catheterization. These catheters have balloons located on the exterior of their distal ends and have been used for many years to hold the catheters in place in a patient's rectum. Such catheter systems are frequently used for enema application but are also used for the collection and directing of fecal material from the rectum to a collection system.
There are many professionals in the medical community who do not approve of the use of inflatable devices in the rectum, as they believe that tissue damage will result from excess pressure exerted on adjacent tissue by the inflated balloon for an extended time. Such tissue necrosis is believed to occur when the pressure from the balloon prevents the tissue from being sufficiently profused by blood.
In practice, after these Foley-type catheters are inserted into the rectum, the balloon is inflated to its full size, regardless of the pressure that it exerts on tissue. Thus, the size of the balloon selected becomes critical. However, since the caregiver has no knowledge of the internal anatomy of the patient, the choice of balloon size is no more than a guess.
Known prior art systems suffer from this problem. The balloon can be inflated to a pressure that could result in prevention of the tissue from being sufficiently profused by blood since there appears to be no mechanism to limit the pressure applied to the tissue by the balloon.
Further, in order to conveniently insert the end of a catheter into the rectum or stoma, the end must have sufficient rigidity. If the end of the catheter does not have sufficient rigidity, it can be quite difficult to insert and properly position the end of the catheter. The distal end of known rectal catheters includes a rigid portion to permit insertion and positioning of the catheter into the bowel.
It is possible to build devices designed to be inserted in the bowel with sufficient rigidity to permit insertion but it is usually detrimental to have such rigidity once the device is properly positioned. Many products use rigid tube systems for insertion. One such system is disclosed in U.S. Pat. No. 4,516,578 issued May 14, 1985 to Shuffield entitled “Rectal Device and Method of Inserting Same”. In those devices, the portion of the device to be inserted is compressed within one tube. That tube is inserted in the desired location within the bowel. The device is then pushed out of the end of the first tube by a second member (usually a smaller nesting tube).
That system requires a hard outer tube to hold the device in its compressed form as it is inserted. The outer tube also has to be rigid to allow the device to be pushed out of it without stretching. Finally, the hard outer tube has to be strong enough to hold the device in its compressed form but still thin enough to minimize the diameter of the insertion system.
There are several shortcomings resulting from that type of insertion system. First, the hard outer tube can have traumatic impact to soft tissue. This is especially true as the wall thickness of the outer tube is reduced to minimize the diameter of the assembly. The thin tube wall causes difficulty in avoiding sharp edges at the tube end or along any openings in the tube. This is especially detrimental if the outer tube needs to be split along one side of its length to allow removal of the device from the side of the assembly. The sharp edge would be evident along the length of the tube, resulting in the potential for tissue damage.
Further, the requirement for the rigidity in the hard outer tube results in a greater than desired wall thickness to ensure sufficient strength. Finally, the hard outer tube can result in excess tissue bruising, simply because it is hard.